Horizon receives authorization to increase Tepezza production
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Horizon Therapeutics has received a prior approval supplement for its previously approved biologics license application so that it can manufacture more Tepezza for the treatment of thyroid eye disease, according to a press release.
“We are pleased that patients who have had to struggle with the debilitating effects of thyroid eye disease will soon have access again to Tepezza, the only FDA-approved medicine to treat this rare disease, and we appreciate their patience and understanding during this unfortunate disruption,” Tim Walbert, chairman, president and CEO of Horizon, said in the release.
The supply disruption began in December 2020 when U.S. government orders began to prioritize the production of COVID-19 vaccines. The new approval grants Horizon the ability to increase the number of vials of Tepezza (teprotumumab) in each manufacturing slot, the release said.
“With regard to deciding how to resume Tepezza treatment once the drug again becomes available, I will generally advise administration of the next scheduled dose and completion of the full eight infusion course that was used in both clinical trials,” Terry J. Smith, MD, said in a Healio/OSN article posted March 11, 2021.
Horizon recommends physicians with questions to call 1-866-479-6742 or email medicalinformation@horizontherapeutics.com.
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